Concerns over body image, specifically fat, have often been a reason for image conscious individuals to seek various treatments for the treatment of fat. Such treatments include surgical options (such as liposuction, which basically “vacuums” fat out of the body via one or more incisions), “nonsurgical procedures”, including COOLSCULPTING® (which appears to cause reperfusion injury to subcutaneous fat, and consequent adipocyte death), and injections of various chemical, not all of which are approved for such treatment—one such example of an approved treatment is KYBELLA® in the US, a first in class drug, which is injectable deoxycholic acid that causes adipolysis in situ via an injection of the drug. Some companies are exploring other injectable therapies—other unapproved injections such as ESSENTIALE® and LIPOSTABIL® do exist.
However, surgical and device related procedures, including liposuction, lipoplasty or suction lipectomy involve the surgical removal of fat deposits using suction, optionally assisted by certain solutions to facilitate fat removal. Liposuction removes fat through an incision in the skin and fat is aspirated by suction through a cannula while the patient is under some sort of anesthesia.
Sometimes liposuction uses fluid injection methodologies wherein a medicated solution containing a mixture of salts, anesthetics and vasoconstrictors or other actives are infused into the treatment site. Examples of adjuvant solutions for liposuction are found in U.S. Pat. No. 5,891,083 ('083). For example, '083 discloses an enzyme, such as a lipase or colipase, added to a carrier. In every embodiment of '083, the solution is administered prior to liposuction. Nowhere in '083 is the use of such a solution alone disclosed as a non-surgical means for removing fat from the body.
Liposuction and device-related methods of fat removal are associated with significant adverse events including temporary bruising, swelling, numbness, soreness and burning sensation, risk of infection, pigmentation changes, the formation of fat clots or blood clots, excessive fluid loss (which can lead to shock) or fluid accumulation that must be drained, friction burns (or other damage to the skin or nerves), or perforation injury to the vital organs. Additionally, such methods often require a recovery time of one to two weeks wherein the patient cannot perform certain daily activities. Moreover, because surgical procedures such as liposuction require local and occasionally general anesthesia, significant anesthesia-related risks are associated with surgical fat removal.
Therefore, it would be desirable to have a method of removing localized fat accumulations that does not require surgery or prolonged recovery time and has fewer adverse side effects than currently available methods.
In each of these procedures, surgical and non-surgical, the attendant risks of such treatments are apparent, thus there has been a desire to provide a less invasive method of treatment. For example, Topokine Therapeutics is exploring a non-invasive topical treatment referred to as XAF5 OINTMENT. While such research continues, the need for a safe and effective non-invasive composition to treat subcutaneous fat remains.